An appraisal of the regulatory policies governing the use of herbal traditional medicine

Abstract

The regulation of herbal traditional medicine (HTM) is of much importance as it ensures the safety, quality and efficacy thereof. However, there are variations in the regulation of HTM worldwide with some countries being more supportive of HTM than others. This literature review aimed to evaluate and compare the regulatory policies governing the use of HTM in developed and developing countries as well as to determine the regulatory challenges faced by regulatory authorities and governments across the world. The countries investigated in this study were Germany, the United States of America, Japan, South Africa, China and India. Variations were evident between countries, however, Germany and Japan were found to be more advanced with regards to the regulation of HTM. Germany and Japan had stricter regulatory policies and lesser safety concerns. South Africa and the United States of America appear to have inadequate or ineffective HTM regulatory systems which was seen by the countries’ limited or lack of regulations and additional safety concerns. The findings showed the difference in HTM regulation between developed and developing countries were not as large as could be expected. The United States of America (developed country) was found to have poor HTM regulations, while China and India (developing countries) were found to have thorough regulations. The findings also show that both developed and developing countries continue to face challenges with regards to establishing regulations and registration procedures for HTM.